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LACTINEX ®: Scientific Study

Lactinex ®: Scientific Study
Falugue D.l .Torres A., Zukierman D.G.:
"Assessment of treatment with Lactobacillus acidophilus vaginal ovuli before taking samples for cervical cytological smear”.
Is it possible to decrease the percentage of improper cytological samples?" Congreso Conjunto [Joint Congress] 2004, Poster Nº 169. Magazine of the Sociedad de Obstetricia y Ginecología de la Provincia de Buenos Aires [Association of Obstetrics and Gynecology of the Province of Buenos Aires].
(2004) Page 362, Vol 35 Nº 189. SOGBA Mar del Plata. Prize to the Best Poster of Gynecology.

Introduction:

After having shown in a previous study (2) the efficacy of treatment with polyvalent vaginal ovuli to decrease the indexes of improper cytological samples in a population in which the index of reports indicating “very inflammatory smear, treat and repeat” was of 37.6 %, and after the introduction in the Argentine market of Lactobacillus acidophilus vaginal ovuli, our aim was to assess whether the systematic treatment with those vaginal ovuli before performing the Pap smear could improve significantly the quality of smears and thus decrease the percentage of repetition of same, with subsequent saving of material (for both the patient and the Institution), and obtaining a cytological smear apt for a faster reading and thus avoid numerous post-treatment appointments.

Objectives:

To show whether treatment with Lactobacillus acidophilus vaginal ovuli before performing the Pap smear decreased the percentages of inflammatory smears non-apt for assessment.

Materials y Methods:

Two-hundred consecutive patients appointed for control at the Low Genital Tract Pathology and Colposcopy unit of the Hospital Dr. Carlos Bocalandro of Loma Hermosa department, Province of Buenos Aires between April 1, and July 1, 2004 were randomly assigned to either one of the 2 groups:

Group A: Without treatment with Lactobacillus acidophilus vaginal ovuli Group B: Previous treatment with Lactobacillus acidophilus vaginal ovuli

Each patient of group B received a sealed thermal bag (Termi.bag® ) containing a box with 6 Lactinex® vaginal ovuli : Lactobacillus acidophilus 108-109 viable Bacteria per ovuli and the respective refrigerant. Patients were instructed to store the ovulis box in the refrigerator between 4 and 8 Cº to keep the cold chain strictly. 13 days before the study, patients were instructed to use 1 vaginal ovuli for 6 nights so as to achieve one week without intra-vaginal medication before taking the cytology sample. At the moment of reading the smears, the Pathological Anatomy Service did not know to which group each of them belonged to. The patients’ ages, their menopausal status and the need to reiterate the study due to inflammatory smear were assessed. Results were statistically analyzed by means of the Chi Square test for independence (Statistics 7.0)

Inclusion criteria:

Any patient attending for a control test that did not meet one or more exclusion criteria.

Exclusion criteria:

1) Patients receiving local and/or systemic treatment for infectious pathology at the low genital tract during the last 2 months.
2) Symptomatic patients or patients whose reason for the visit were other than the “periodical control”
3) Patients unable to comply with the cold chain requirement.


Results:

100 were included in each group, of which, for different reasons (non-attendance to the study, incompliance with the baseline conditions, incompliance with the cold chain, menstruation, etc.) 81 were eligible for group A y 89 for group B.

The percentage of lost patients between both groups did not reveal a statistically significant difference. No significant differences were found in the ages or menopausal status.

In group A, 33 (40.7%, CI 95% 29.4-52.0) of 81 patients presented inflammatory smears with indication to repeat them after treatment.

In group B, 13 patients (14.6% IC 95 % 6.7-22.5) of 89 needed to repeat the smears due to inflammatory changes.

The difference of proportions was highly significant as from the statistical point of view at a level of p < 0.001.

When comparing both groups, a notable improvement was observed in the appropriateness of the cytological sample for its reading in the group treated with Lactobacillus acidophilus vaginal ovuli, as shown in the following graph.

Percentage of rejection of cytological smears

Treatment with Lactobacillus acidophilus ovuli reduced the rate of unsatisfactory smears and improved the quality of the smears for an appropriate interpretation of them.

Group A: Without previous treatment Group B : Treatment with Lactobacillus acidophilus vaginal ovuli

Conclusions:

As from the practical point of view, according to a retrospective analysis of our population, 4 of 10 patients attending for a cervical pathology control had to return to repeat the study after a specific treatment, with subsequent lost profits, travel to the Hospital and absenteeism at work for patients, and use of disposable materials, reagents and medical hours for the Service. Previous treatment with Lactobacillus acidophilus vaginal ovuli improved notably the quality of cervical cytological smears and decreased, in a statistically significant way, the need for repeating them with subsequent benefits for both the Institution and the patient.

Bibliography

1) Falugue D.l , Torres A. , Zukierman D.G.: Evaluación del tratamiento con óvulos de lactobacillus acidophilus previo a la toma de la muestra para extendido citológico cervical. ¿podemos disminuir los porcentajes de muestras citológicas inadecuadas? Congreso Conjunto 2004, Poster Nº 169. Revista de la Sociedad de Obstetricia y Ginecología de la Provincia de Buenos Aires. (2004) Pag 362,Vol 35 Nº 189.

2) Aldini A, Falugue D, Carpetta R., Finkelstein G.: Eficacia del tratamiento sistemático con un óvulo polivalente previo a la toma de la muestra para citología .¿Es posible disminuir el índice de muestras no satisfactorias en nuestra población? Servicio de Ginecología, Sección Patología del Tracto Vaginal Inferior y Colposcopía, Hospital Bocalandro, Loma Hermosa, Pcia. de Buenos Aires. Archivos Dpto Médico Omega.

 

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